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Latest Sedatives Stories

2008-12-14 19:00:00

WOODCLIFF LAKE, N.J., Dec. 14 /PRNewswire/ -- Eisai Corporation of North America today announced that the U.S. Food and Drug Administration (FDA) has approved LUSEDRA(TM) (fospropofol disodium) Injection, an intravenous sedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures. In the approval, the FDA required that LUSEDRA be used only by persons trained in the administration of general anesthesia and that...

2008-10-28 06:00:11

US-based pharmaceutical company Sepracor has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion recommending to grant a marketing authorization for Lunivia brand eszopiclone in the EU for the treatment of insomnia. The EU labeling provides for patients who require longer-term therapy to be treated for up to six months, with the usual course of therapy for typical patients being short term. Lunivia is marketed in the US...

2008-10-24 06:00:24

Sepracor Inc. (Nasdaq: SEPR) today announced that the EMEA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending to grant a marketing authorization for LUNIVIA(R) brand eszopiclone in the European Union (EU) for the treatment of insomnia. The EU labeling provides for patients who require longer-term therapy to be treated for up to six months, with the usual course of therapy for typical patients being short-term. LUNIVIA is marketed in the U.S....

2008-10-22 09:00:42

PT. RICHMOND, Calif., Oct. 22 /PRNewswire/ -- Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced today that a Phase 3 study evaluating the safety and efficacy of its lead product candidate, Intermezzo(R) (zolpidem tartrate sublingual lozenge), has been published in the September 2008 issue of SLEEP, a publication of the Associated Professional Sleep Societies. Intermezzo(R) is a low dose, buffered, sublingual formulation of zolpidem intended to be...

2008-10-13 09:00:49

AstraZeneca has received the FDA's approval for once-daily Seroquel extended-release tablets for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex. Seroquel extended-release (XR) is said to be the first medication approved by the FDA for the once-daily acute treatment of both depressive and manic...

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2008-10-08 13:50:00

U.S. government scientists convened in an online chat room Tuesday to answer questions about drugs and alcohol coming from students during the National Institute on Drug Abuse's second-ever Drug Facts Chat Day.  "How many drinks does it take to get you drunk?" asked an anonymous teenager at George Washington High School in California. "For a person of normal weight not used to alcohol, about four-five drinks within one hour," came the answer. Another student from Sanborn Regional High...

2008-09-22 03:00:30

AACHEN, Germany and CAMBRIDGE, UK, Sept. 22, 2008 (GLOBE NEWSWIRE) -- The biopharmaceutical company PAION AG (ISIN DE000A0B65S3) (Frankfurt:PA8) (London AIM: PAI) today announces that its Phase I study with its sedative CNS 7056 has progressed to the dose levels that induce pronounced sedation. In addition, the first group including a comparison with midazolam, the current gold standard for procedural sedation has been completed. So far no safety concerns were raised by the Drug Safety...

2008-09-19 09:00:40

NovaDel Pharma, a specialty pharmaceutical company, has announced that the FDA has requested an extension of up to three months on the Prescription Drug User Fee Act deadline in order to complete the review of the company's Zolpimist oral spray for the short-term treatment of insomnia. Based on the original Prescription Drug User Fee Act (PDUFA) date for Zolpimist, the FDA will reply on or before December 19, 2008. NovaDel submitted its Zolpimist application using the FDA's 505(b)(2)...

2008-09-18 18:00:19

NovaDel Pharma Inc. (AMEX: NVD) today announced that the U.S. Food and Drug Administration (FDA) has requested an extension of up to 3 months on the Prescription Drug User Fee Act (PDUFA) deadline in order to complete the review of the Company's Zolpimist (zolpidem tartrate) Oral Spray for the short-term treatment of insomnia. Based on the original PDUFA date for Zolpimist, the FDA will reply on or before December 19, 2008. "We believe we have submitted a high quality 505(b)(2) application...

2008-09-09 15:00:09

-- Elderly patients taking LUNESTA 2 mg showed significant improvements in measures of daytime function compared to placebo over a 12-week treatment period -- Elderly patients administered LUNESTA 2 mg showed no evidence of rebound insomnia and withdrawal symptoms were comparable to the placebo group upon discontinuation Sepracor Inc. Jonae R. Barnes, 508-481-6700 Sr. Vice President, Investor Relations & Corporate Communications Sepracor Inc. (Nasdaq: SEPR) today announced the...


Word of the Day
tessitura
  • The prevailing range of a vocal or instrumental part, within which most of the tones lie.
This word is Italian in origin and comes from the Latin 'textura,' web, structure.